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Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Saxagliptin as Monotherapy in Pediatric Patients With Type 2 Diabetes

This study is currently recruiting participants.
Verified February 2012 by Bristol-Myers Squibb
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01204775
First received: September 16, 2010
Last updated: March 28, 2013
Last verified: February 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the efficacy, safety, tolerability, of Saxagliptin in pediatric patients with type 2 diabetes.


Condition Intervention Phase
Type 2 Diabetes
 Drug: Saxagliptin
Drug: Placebo (Saxagliptin)
Drug: Metformin IR
Drug: Placebo (Metformin)
Drug: Metformin (Active Rescue)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Saxagliptin (BMS-477118) as Monotherapy in Pediatric Patients With Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • To compare after 16 weeks of oral double-blind treatment the change from baseline in HbA1c achieved with Saxagliptin and placebo [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare after 16 weeks of oral double-blind treatment the effects of Saxagliptin versus placebo treatment on the AUC change from baseline in 2-hour PPG levels, as determined from samples obtained during Mixed Meal Tolerance Test (MMTT). [ Time Frame: 16 weeks (or last measurement prior if no Week 16 assessment is available) ] [ Designated as safety issue: No ]
    Area under the curve (AUC), Postprandial Glucose (PPG)

  • To compare after 16 weeks of oral double-blind treatment the effects of Saxagliptin versus placebo treatment on the change from baseline in Fasting Plasma Glucose (FPG). [ Time Frame: 16 weeks (or last measurement prior if no Week 16 assessment is available) ] [ Designated as safety issue: No ]
  • To compare after 16 weeks of oral double-blind treatment the effects of Saxagliptin versus placebo treatment on the percent of subjects who achieved Glycosylated hemoglobin (HbA1c) < 7% [ Time Frame: 16 weeks (or last measurement prior if no Week 16 assessment is available) ] [ Designated as safety issue: No ]

Estimated Enrollment: 136
Study Start Date: June 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Saxagliptin or Placebo Drug: Saxagliptin
Tablets, Oral, 2.5 mg or 5.0 mg (according to body weight category), Once Daily, 1-52 weeks
Other Names:
  • BMS-477118
  • Onglyza
Drug: Placebo (Saxagliptin)
Tablets, Oral, 0 mg, Once daily, 1-52 weeks
Active Comparator: Metformin IR or Placebo Drug: Metformin IR
Tablets, Oral, 500 mg, Once Daily, 17-52 weeks
Drug: Placebo (Metformin)
Tablets, Oral, 0 mg, Once daily, 1-52 weeks
Metformin IR
Active Rescue
 Drug: Metformin (Active Rescue)
Tablets, Oral, 500 mg, Titrated as needed, 2-52 weeks

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients eligible if 10 years of age, up to 17 years and 32 weeks of age at the time of randomization.
  • HbA1c ≥7.0% and ≤10.5%

Exclusion Criteria:

  • Current use of anti-diabetic medications or use within the specified timeframe prior to screening.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01204775

Contacts
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

  Hide Study Locations
Locations
United States, Alabama
Univ Alabama At Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Gail Mick, Site 1040     205-996-9569        
United States, California
Neufeld Medical Group Recruiting
Los Angeles, California, United States, 90048
Contact: Naomi Neufeld, Site 1023     310-652-3976        
Perinatal And Pediatric Endocrinology Recruiting
Sacramento, California, United States, 95819
Contact: Gnangurudasan Prakasam, Site 1025     916-733-0888        
Rady Children'S Hospital - San Diego Recruiting
San Diego, California, United States, 92123
Contact: Ron Newfield, Site 1024     858-966-4032        
Ronald Chochinov Md Inc Recruiting
Ventura, California, United States, 93003
Contact: Ronald Chochinov, Site 1011     805-667-3909        
United States, Colorado
Children'S Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Megan Kelsey, Site 1043     720-777-6673        
United States, Florida
Boca Raton Clinical Research Associates, Inc. Recruiting
Boca Raton, Florida, United States, 33498
Contact: Dhruti Pandya, Site 1060     561-447-0614        
University Of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Tossaporn Seeherunvong, Site 1041     305-243-2929        
Miami Children'S Hospital Suspended
Miami, Florida, United States, 33155
Flcri Global Research, Llc Recruiting
Miami, Florida, United States, 33125
Contact: Jorge Alsina, Site 1070     305-642-7000        
Arnold Palmer Hosp Ped Endocrinology Specialty Practice Recruiting
Orlando, Florida, United States, 32806
Contact: Joshua Yang, Site 1071     407-786-9715        
Wright, Nancy Recruiting
Tallahassee, Florida, United States, 32308
Contact: Nancy Wright, Site 1033     850-656-3361        
United States, Illinois
Alianza Research, Inc. Recruiting
Chicago, Illinois, United States, 60611
Contact: Giovanni Infusino, Site 1068     608-358-0001        
St. James Ctr For Diabetes Recruiting
Olympia Fields, Illinois, United States, 60461
Contact: Arcot Dwarakanathan, Site 1062            
United States, Louisiana
Lsu Health Sciences Center Suspended
New Orleans, Louisiana, United States, 70118
United States, Michigan
Alzohaili Medical Consultants Recruiting
Dearborn, Michigan, United States, 48124
Contact: Opada Alzohaili, Site 1004     313-945-6100        
United States, Missouri
St. Louis Children'S Hospital Recruiting
St. Louis, Missouri, United States, 63110
Contact: Neil White, Site 1056     314-286-1157        
United States, Montana
Billings Clinical Research Center Recruiting
Billings, Montana, United States, 59101
Contact: Christopher Sorli, Site 1058     406-255-8473        
United States, New Jersey
Hackensack University Medical Center Suspended
Hackensack, New Jersey, United States, 07601
Local Institution Not yet recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Site 1021            
United States, New York
Women And Children'S Hopsital Of Buffalo Recruiting
Buffalo, New York, United States, 14222
Contact: Lucy Mastrandrea, Site 1039     716-878-7588        
Local Institution Not yet recruiting
Mineola, New York, United States, 11501
Contact: Site 1001            
United States, North Carolina
East Carolina University Recruiting
Greenville, North Carolina, United States, 27834
Contact: Glenn Harris, Site 1064     252-744-3326        
United States, Ohio
Akron Children'S Hospital Recruiting
Akron, Ohio, United States, 44308
Contact: Berrin Ergun-Longmire, Site 1014     330-543-4896        
Ohio University College Of Osteopathic Medicine Recruiting
Athens, Ohio, United States, 45701
Contact: Jay Hawthorne Shubrook, Site 1032     740-566-4873        
United States, Oregon
Cyn3rgy Research Recruiting
Gresham, Oregon, United States, 97030
Contact: Frank Calcagno, Site 1009     503-491-0714        
United States, Tennessee
Holston Medical Group Recruiting
Kingsport, Tennessee, United States, 37660
Contact: Joseph Ley, Site 1019     423-230-2430        
Methodist Le Bonheur Hlthcare Recruiting
Memphis, Tennessee, United States, 38103
Contact: Robert Ferry, Site 1036            
United States, Virginia
Va Commonwealth University (Vcu) Health Systems Recruiting
Richmond, Virginia, United States, 23219
Contact: Gary Francis, Site 1015     804-828-6703        
United States, Washington
Seattle Children'S Hospital Suspended
Seattle, Washington, United States, 98105
Argentina
Local Institution Suspended
Rosario, Santa Fe, Argentina, S2000COD
Local Institution Suspended
Buenos Aires, Argentina, C1425DUC
Belgium
Local Institution Recruiting
Yvoir, Namur, Belgium, 5530
Contact: Site 3601            
Local Institution Suspended
Brussel, Belgium, 1090
Canada, Alberta
Local Institution Recruiting
Calgary, Alberta, Canada, T2N 1N4
Contact: Site 1044            
Canada, Quebec
Local Institution Suspended
Montreal, Quebec, Canada, H3H 1P3
India
Local Institution Suspended
Kamal, Haryana, India, 132001
Italy
Local Institution Recruiting
Chieti, Italy, 66013
Contact: Site 3108            
Local Institution Not yet recruiting
Firenze, Italy, 50139
Contact: Site 3107            
Local Institution Recruiting
Milano, Italy, 20157
Contact: Site 3111            
Local Institution Recruiting
Modena, Italy, 41100
Contact: Site 3104            
Local Institution Recruiting
Napoli, Italy, 80138
Contact: Site 3103            
Local Institution Recruiting
Palermo, Italy, 90127
Contact: Site 3102            
Local Institution Recruiting
Roma, Italy, 00185
Contact: Site 3100            
Local Institution Suspended
Tento, Italy, 38100
Local Institution Recruiting
Torino, Italy, 10126
Contact: Site 3109            
South Africa
Local Institution Recruiting
Benoni, Gauteng, South Africa, 1500
Contact: Site 5103            
Local Institution Recruiting
Potchefstroom, Gauteng, South Africa, 2531
Contact: Site 5102            
Local Institution Recruiting
Dundee, Kwa Zulu Natal, South Africa, 3000
Contact: Site 5101            
Local Institution Recruiting
Cape Town, Western Cape, South Africa, 7550
Contact: Site 5104            
Taiwan
Local Institution Not yet recruiting
Taipei, Taiwan, 100
Contact: Site 4202            
Sponsors and Collaborators
Bristol-Myers Squibb
AstraZeneca
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site
BMS clinical trial educational resource  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01204775     History of Changes
Other Study ID Numbers: CV181-058, 2010-020360-38
Study First Received: September 16, 2010
Last Updated: March 28, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Canada: Office of Clinical Trials - Therapeutic Products Directorate
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
India: Central Drugs Standard Control Organization
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: Ministry of Health
Italy: National Bioethics Committee
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency
Mexico: Federal Commission for Sanitary Risks Protection
Mexico: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Russia: FSI Scientific Center of Expertise of Medical Application
South Africa: Medicines Control Council
Sweden: Medical Products Agency
Sweden: The National Board of Health and Welfare
Sweden: The Swedish Data Inspection Board
Sweden: Central Ethics Board
Taiwan: Department of Health
Taiwan: National Bureau of Controlled Drugs
Turkey: Ministry of Health
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Saxagliptin
Metformin
 Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013